Device and method for collecting dissociation component analysis sample of implant material

By using circulation pipelines and tee switches in the sample collection device for dissociation components of implantable interventional material simulation of in vivo circulation, dynamically collecting degraded substances of medical devices and automatically supplementing experimental media, the problem of inability to monitor the degradation process in the prior art is solved. Research on the degradation of medical devices and the impact of drugs has been achieved.

CN119198196APending Publication Date: 2024-12-27FUWAI HOSPITAL CHINESE ACAD OF MEDICAL SCI & PEKING UNION MEDICAL COLLEGE
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Patent Information

Application Number
CN202411512265.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-28
Publication Date
2024-12-27

AI Technical Summary

Technical Problem

The prior art cannot monitor the degradation process of medical devices, cannot dynamically collect degraded substances, and cannot meet the research needs of in vitro research drugs on the degradation process of medical devices.

Method used

Provide a sample collection device for the analysis of dissociation components of implant interventional materials, including circulation pipelines, sample loading chambers, heating equipment, liquid driving equipment and tee switches. Through the closed circulation experimental pipeline, the degradation of medical devices is dynamically collected. and automatically supplement the experimental medium through pressure sensing switch to achieve dynamic addition and real-time monitoring of drugs.

Benefits of technology

It realizes in vitro simulation of human circulation, dynamic collection of degradable substances in medical devices, analyzes the dissociation components of degradable materials and drug release speed, meets the research needs for the degradation process of medical devices, and provides a convenient platform for evaluating coupling technology.

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Abstract

The invention belongs to the technical field of polymer medical instrument experiments, and particularly relates to a device and a method for collecting dissociation component analysis samples of an implant material. The device comprises a circulation pipeline; a sample loading cavity, heating equipment and liquid driving equipment which are communicated with one another are arranged on the circulating pipeline, and the sample loading cavity, the heating equipment and the liquid driving equipment form a closed circulating experiment pipeline through the circulating pipeline; the closed circulation experiment pipeline is filled with an experiment medium; a fixing assembly is arranged on the sample loading cavity, and the fixing assembly is used for loading a polymer medical device to be experimented in the sample loading cavity; any section of circulating pipeline is provided with a first branch, the first branch is communicated with a three-way switch used for sample / medicine injection and sample collection, and the three-way switch is communicated with the first branch, an external sampling device and a medicine injector. In-vitro human body circulation simulation can be achieved, and medical instrument degradation products are dynamically collected.
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Description

Technical Field

[0001] The invention belongs to the technical field of polymer medical device experiments, and in particular relates to a sample collection device and method for analyzing dissociated components of implant intervention materials. Background Art

[0002] High-performance polymer materials have been widely used in medical device products. Since it needs to be in direct contact with the drug solution and the human body, medical polymers are also more stringent in the risk control of regulatory authorities. In vitro degradation studies of polymer medical devices have become an important part of product safety evaluation. According to GB / T16886.1-2022, collecting physical or chemical information of medical devices or components is a crucial first step in the biological evaluation process and related material characterization. For example, the degradation rate of new drug coating materials such as polylactic acid (PLA) and polyalkylene glycol acetic acid (PLGA) is directly related to the drug release capacity, safety and effectiveness, and is also related to the final therapeutic effect. In addition, when clinical patients take some drugs, they will also affect the surface properties, surrounding microenvironment, degradation rate, etc. of medical devices in the body. Therefore, before clinical trials, it is crucial to study the degradation properties of materials and the effects of drugs on them.

[0003] However, there is currently a lack of dynamic collection devices for the degradation products of medical devices, which makes it impossible to monitor the degradation process of medical devices, dynamically collect the degradation products of medical devices, and meet the needs of in vitro research on the impact of drugs on the degradation process of medical devices. Summary of the invention

[0004] The purpose of the present invention is to provide a sample collection device and method for analyzing the dissociated components of implantable materials, so as to solve the problems in the prior art that the degradation process of medical devices cannot be monitored, the degradation products of medical devices cannot be dynamically collected, and the needs of in vitro research on the impact of drugs on the degradation process of medical devices cannot be met.

[0005] In order to achieve the above object, the present invention adopts the following technical solution: In a first aspect, the present invention provides a sample collection device for analyzing dissociated components of implantable materials, comprising: Circulation pipeline; The circulation pipeline is provided with a sample loading cavity, a heating device and a liquid driving device which are connected to each other, and a closed circulation experimental pipeline is formed between the sample loading cavity, the heating device and the liquid driving device through the circulation pipeline; the heating device is provided with a heating device control panel, and the heating device control panel is used to control the heating device and display heating-related parameters; the liquid driving device is provided with a liquid driving device control panel, and the liquid driving device control panel is used to set the control parameters of the liquid driving device and display the flow rate and pressure data of the circulation pipeline; The closed-loop experimental pipeline is filled with an experimental medium; The sample loading cavity is provided with a fixing component, and the fixing component is used to load the polymer medical device to be tested into the sample loading cavity; A first branch is arranged on any section of the circulation pipeline, and the first branch is connected with a three-way switch for drug / sample injection and sample collection, and the three-way switch is connected with the first branch, an external sampling device and a drug injector.

[0006] Furthermore, a second branch is provided on any section of the circulation pipeline, the second branch is connected to the circulation pipeline and an external liquid storage bottle, and a pressure sensing switch is provided on the second branch.

[0007] Furthermore, the fixing assembly includes a distance adjusting member and a contact mounting member; the distance adjusting member is mounted on the sample loading cavity, the contact mounting member is disposed within the sample loading cavity, the contact mounting member is connected to the distance adjusting member and can move under the adjustment of the distance adjusting member.

[0008] Further, the distance adjusting member is a bolt, and the contact mounting member is an extrusion plate; The bolt is rotatably connected to the sample loading cavity; the first end of the bolt is located in the sample loading cavity and is installed with the pressing plate.

[0009] Furthermore, the distance adjustment member may also be a bolt, and the contact mounting member may be a spring clip; The bolt is rotatably connected to the sample loading cavity; the first end of the bolt is located in the sample loading cavity and is installed with the spring clip.

[0010] Furthermore, the fixing components include at least two pairs, and each pair of fixing components are arranged opposite to each other.

[0011] Furthermore, a knob is provided at the second end of the bolt.

[0012] Furthermore, a sealing member is provided at the position where the bolt and the sample loading chamber meet.

[0013] Furthermore, the sample loading chamber is a cylindrical sealing structure, an operation port is provided on the cylindrical sealing structure, and a sealing door is provided at the operation port.

[0014] In a second aspect, the present invention provides a method for collecting samples for analyzing dissociated components of implantable materials, which is implemented based on the above-mentioned sample collection device for analyzing dissociated components of implantable materials, and includes the following steps: The polymer medical device to be tested is loaded into the sample loading cavity through a fixing component; Turn on the liquid driving device and heating device, set the driving device flow rate, flow rate and pressure parameters, heat the experimental medium (if necessary), start the cycle, and start the experiment; At a predetermined time point, the valve position of the three-way switch is adjusted to allow the experimental medium to flow out, thereby completing the collection of the experimental medium sample.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: The present invention provides a sample collection device for analyzing dissociated components of implantable materials, comprising: a circulation pipeline; a sample loading cavity, a heating device and a liquid driving device are arranged on the circulation pipeline, and a closed circulation experimental pipeline is formed between the sample loading cavity, the heating device and the liquid driving device through the circulation pipeline; the closed circulation experimental pipeline is filled with an experimental medium; a fixed component is arranged on the sample loading cavity, and the fixed component is used to load the polymer medical device to be tested in the sample loading cavity; a first branch is arranged on any section of the circulation pipeline, and the first branch is connected to a three-way switch for drug / sample injection and sample collection, and the three-way switch is connected to the first branch, an external sampling device and a drug injector. It can realize in vitro simulation of human circulation and dynamically collect medical device degradation products. It provides convenience for subsequent analysis of the dissociated components of degradable materials, the drug release rate and duration of drug-eluting stents, and evaluation of coupling technology.

[0016] The present invention can realize dynamic addition of drugs by providing a three-way switch for drug / sample injection and sample collection, which is conducive to exploring the influence of drugs on processes such as medical device degradation.

[0017] The present invention is provided with a pressure sensing switch, which cooperates with the liquid storage bottle while monitoring the pressure of the circulation pipeline in real time, and can dynamically supplement the experimental medium lost due to collecting samples, thereby maintaining the expected circulation volume and pressure of the experiment.

[0018] The present invention provides fixing components of different forms and corresponding sample loading elements, which can meet the needs of experimental objects with different shapes and characteristics, and are convenient for fixing, observing and assembling. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings: Figure 1 It is an overall connection diagram of a sample collection device for analyzing dissociated components of implant intervention materials according to an embodiment of the present invention.

[0020] Figure 24 is a front view of a sample loading chamber for fixing a tubular experimental object in an embodiment of the present invention.

[0021] Figure 3 1 is a side view of a sample loading chamber for fixing a tubular experimental object in an embodiment of the present invention.

[0022] Figure 4 1 is a front view of a sample loading chamber for fixing a sheet-shaped experimental object in an embodiment of the present invention.

[0023] Figure 5 1 is a side view of a sample loading chamber for fixing a sheet-shaped experimental object in an embodiment of the present invention.

[0024] In the figure: 1. sample loading chamber; 2. circulation pipeline; 3. three-way switch; 4. heating device; 5. heating device control panel; 6. liquid driving device; 7. liquid driving device control panel; 8. pressure sensing switch; 9. liquid storage bottle; 10. bolt; 11. extrusion plate; 12. spring clip. DETAILED DESCRIPTION

[0025] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present application can be combined with each other without conflict.

[0026] The following detailed description is an exemplary description, which is intended to provide further detailed description of the present invention. Unless otherwise specified, all technical terms used in the present invention have the same meaning as those generally understood by those skilled in the art to which the present application belongs. The terms used in the present invention are only for describing specific embodiments, and are not intended to limit exemplary embodiments according to the present invention.

[0027] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0028] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, the meaning of "multiple" is two or more. In the description of the present invention, it should be noted that, unless otherwise clearly specified and defined, the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be a connection between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0029] Example 1 like Figure 1~Figure 5 As shown, Example 1 of the present invention provides a sample collection device for analyzing dissociated components of implantable materials, which can dynamically collect degradation substances of medical devices and study the effects of drugs on medical devices under conditions simulating in vivo circulation.

[0030] The device includes the following components: Circulation line 2; The circulation pipeline 2 is provided with a sample loading chamber 1, a heating device 4 and a liquid driving device 6 which are connected to each other. The sample loading chamber 1, the heating device 4 and the liquid driving device 6 form a closed circulation experimental pipeline through the circulation pipeline 2. The closed-loop experimental pipeline is filled with an experimental medium; The sample loading cavity 1 is provided with a fixing component, and the fixing component is used to load the polymer medical device to be tested into the sample loading cavity 1; A first branch 21 is provided on any section of the circulation pipeline 2. The first branch 21 is connected to a three-way switch 3 for drug / sample injection and sample collection. The three-way switch 3 connects the first branch 21, an external sampling device and a drug injector.

[0031] The solution provided in the above embodiment, by setting up a sample loading cavity 1, a heating device 4 and a liquid driving device 6, and forming a closed circulation experimental pipeline through a circulation pipeline 2, injecting an experimental medium into the closed circulation experimental pipeline, can simulate extracorporeal circulation and dynamically collect medical device degradation products.

[0032] The three-way switch 3 can switch the flow direction of the pipeline by rotating the valve to achieve the injection of experimental media or drugs and dynamic collection of samples. Drugs can be dynamically added through the three-way switch 3 to explore the effects of drugs on degradable materials, drug coating materials, etc.

[0033] The applicant needs to explain that the connection order of the sample loading chamber 1, the heating device 4 and the liquid driving device 6 in this embodiment is not limited, and the sample loading chamber 1, the heating device 4 and the liquid driving device 6 may be connected in sequence, or the heating device 4, the sample loading chamber 1 and the liquid driving device 6 may be connected in sequence, or the heating device 4, the liquid driving device 6 and the sample loading chamber 1 may be connected in sequence, etc. This connection method will not affect the technical effect of this solution.

[0034] In a specific embodiment, a second branch 22 is provided on any section of the circulation pipeline 2 , the second branch 22 connects the circulation pipeline 2 and an external liquid storage bottle 9 , and a pressure sensing switch 8 is provided on the second branch 22 .

[0035] The pressure sensing switch 8 is used to monitor the real-time pressure of the circulation pipeline, and the liquid storage bottle 9 is used to store the experimental medium.

[0036] In this solution, by setting up a second branch 22, a liquid storage bottle 9 and a corresponding pressure sensing switch 8, the liquid storage bottle 9 stores the experimental medium. The pressure in the circulation pipeline 2 can be sensed and the pressure sensing switch 8 can be automatically opened at a preset pressure level to extract the experimental medium in the liquid storage bottle 9. After sampling, the experimental medium in the circulation pipeline 2 is replenished.

[0037] Specifically, when it is detected that the actual pressure of the circulation pipeline is lower than the set pressure value, the pressure sensing switch 8 is in an open state, and the liquid storage bottle 9 is sucked into the circulation pipeline for replenishment to maintain the circulation volume and the set pressure. When the actual pressure of the circulation pipeline returns to the set pressure value, the pressure sensing switch 8 is automatically closed. The experimental medium can be automatically replenished to maintain the circulation volume required for the experiment.

[0038] In a specific embodiment, the fixing assembly includes a distance adjusting member and a contact mounting member; the distance adjusting member is mounted on the sample loading chamber 1, the contact mounting member is disposed within the sample loading chamber 1, and the contact mounting member is connected to the distance adjusting member and can move under the adjustment of the distance adjusting member.

[0039] In this solution, a distance adjusting member is provided and used to adjust the position of the contact mounting member in the sample loading cavity 1, thereby adapting to polymer medical devices of various sizes.

[0040] In an optional embodiment, the distance adjusting member is a bolt 10, and the contact mounting member is a squeezing plate 11; the bolt 10 is rotatably connected to the sample loading chamber 1; the first end of the bolt 10 is located in the sample loading chamber 1 and is installed with the squeezing plate 11.

[0041] In this solution, by providing the squeezing plate 11, it is possible to fix polymer medical devices having a three-dimensional spatial structure, such as tubular test objects, such as artificial blood vessels, etc.

[0042] In an optional embodiment, the distance adjusting member may also be a bolt 10, and the contact mounting member may be a spring clip 12; the bolt 10 is rotatably connected to the sample loading chamber 1; the first end of the bolt 10 is located in the sample loading chamber 1 and is installed with the spring clip 12.

[0043] In this solution, by providing the spring clip 12, a thin-sheet-shaped object to be tested can be clamped and fixed, for example, a heart valve.

[0044] In a preferred embodiment, the fixing components include at least two pairs, and each pair of fixing components are arranged opposite to each other.

[0045] Specifically, the fixing components are arranged opposite to each other in pairs, and at least four fixing components are arranged, and the four fixing components jointly fix the object to be tested.

[0046] In an optional embodiment, more groups of fixing components may be designed according to actual needs to improve the fixing effect.

[0047] In an optional embodiment, a knob is provided at the second end of the bolt 10 to facilitate operation.

[0048] In a preferred embodiment, a seal is provided at the joint between the bolt 10 and the sample loading chamber 1. The seal is used to improve the sealing performance and prevent the experimental medium from leaking out.

[0049] As a specific example, the sample loading chamber 1 is preferably a cylindrical sealing structure, an operation port is provided on the cylindrical sealing structure, and a sealing door is provided at the operation port.

[0050] More specifically, the sample loading chamber 1 is in the shape of a hard transparent tube with both ends sealed, and is used to load and fix the experimental object.

[0051] The two ends of the sample loading chamber 1 are detachably connected to the circulation pipeline 2. When the test object is placed, the sealing door is opened, and the position of the fixing components is pre-adjusted according to the size of the test object; then the test object is limited between the relatively arranged fixing components.

[0052] According to the shape characteristics of the experimental object, different sample loading cavities 1 can be selected for fixation. For tubular experimental objects such as artificial blood vessels, the following can be selected: Figure 2 , 3The sample loading chamber shown in FIG. 4 is used to fix the tubular experimental object. Each fixing assembly is composed of a bolt 10 and a pressing plate 11. The position of the pressing plate 11 can be adjusted by a knob on the bolt 10. For sheet-shaped experimental objects such as artificial valves, the following can be selected: Figure 4 , 5 The sample loading chamber shown in FIG. 4 is used to fix the sheet-like experimental object, each of which is composed of a bolt 10 and a spring clamp 12. The position of the spring clamp 12 can be adjusted by a knob on the bolt 10, and the spring clamp 12 can naturally clamp the sheet-like experimental object.

[0053] For example, the artificial blood vessel is held down by four fixing components to prevent it from moving with the circulating experimental medium.

[0054] The heart valve is clamped with spring clips. Four spring clips clamp the heart valve and unfold it.

[0055] In some other embodiments, the sample loading chamber 1 may also be in other shapes, such as square, oval, etc. The shape is not specifically limited in this solution.

[0056] In an optional embodiment, the heating device 4 is provided with a heating device control panel 5, which is used to control the heating device 4 and display heating related parameters; the liquid driving device 6 is provided with a liquid driving device control panel 7, which is used to set the control parameters of the liquid driving device 6 and display the flow rate and pressure data of the circulation pipeline 2.

[0057] The two control panels are used to control the start and stop of the equipment and set some parameters. For example, the temperature and time setting of the heating device 4 are controlled by the heating device control panel 5, which can simulate the 37°C environment in the human body for real-time degradation testing, or select a temperature higher than 37°C but lower than the melting point or softening range of the polymer for accelerated degradation testing.

[0058] The liquid driving device 6 is responsible for providing stable and continuous experimental medium flow power to ensure smooth circulation of the experimental medium in the circulation system. The liquid driving device control panel 7 thereon can realize the control of the circulation flow, flow rate, direction and pressure.

[0059] Example 2 Based on Example 1, this Example 2 further provides a method for collecting samples for analyzing dissociated components of implantable materials, including the following steps: The sample collection device for analyzing dissociated components of implantable materials based on Example 1 is implemented, comprising the following steps: The polymer medical device to be tested is loaded into the sample loading cavity 1 through a fixing component; Turn on the liquid driving device 6 and the heating device 4, set the flow rate, flow velocity, direction and pressure to heat the experimental medium (if necessary), start the cycle, and start the experiment; At a predetermined time point, the valve position of the three-way switch 3 is adjusted to allow the experimental medium to flow out, thereby completing the collection of the experimental medium sample.

[0060] In a more specific embodiment, according to the shape characteristics of the experimental object, a corresponding sample loading cavity 1 is selected. Before use, the integrity of the device is checked to ensure that it is tightly sealed and no liquid leaks during the circulation process.

[0061] Fix the experimental object in the sample loading chamber 1, and connect the sample loading chamber 1 to the circulation pipeline 2. Adjust the rotary valve of the three-way switch 3 to a suitable position, and inject the experimental medium required for the experiment into the circulation pipeline 2. Then the first end of the three-way switch 3 is connected to the circulation pipeline 2, the second end is connected to the external collection device, and the third end can be connected to the drug syringe as needed.

[0062] Turn on the heating device 4 and adjust the heating device control panel 5 according to the experimental requirements. Turn on the liquid drive device 6 and adjust the liquid drive device control panel 7 according to the experimental requirements to control the flow rate, flow rate, direction and pressure of the circulation. After the circulation is stable, turn on the pressure sensing switch 8. Fill the liquid storage bottle 9 with the experimental medium.

[0063] When the experiment reaches the expected time node, the sample is collected by adjusting the three-way switch 3. After the collection is completed, when the pressure sensing switch 8 senses that the actual pressure of the circulation pipeline is lower than the set pressure value, the switch is in an open state, and the experimental medium in the liquid storage bottle 9 is sucked into the circulation pipeline to replenish the reduced experimental medium and restore to the preset pressure. After the circulation pipeline pressure returns to the preset value, the pressure sensing switch 8 is automatically closed.

[0064] If it is necessary to study the effects of other drugs on the degradation of medical devices, the drugs can be injected into the circulation line 2 through the three-way switch 3, and the drugs react with the experimental object in the sample loading chamber 1. Similarly, when the experiment reaches the expected time node, the sample can be collected by adjusting the three-way switch 3. The pressure sensing switch 8 and the liquid storage bottle 9 replenish the experimental medium.

[0065] In the description of this specification, the description with reference to the terms "one embodiment", "example", "specific example", etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0066] It is known from common technical knowledge that the present invention can be implemented by other embodiments that do not deviate from its spirit or essential features. Therefore, the above disclosed embodiments are only illustrative in all respects and are not exclusive. All changes within the scope of the present invention or within the scope equivalent to the present invention are included in the present invention.

Claims

1. A sample collection device for analyzing dissociated components of implantable materials, characterized in that: include: Circulation line (2); The circulation pipeline (2) is provided with a sample loading chamber (1), a heating device (4) and a liquid driving device (6) which are connected to each other, and the sample loading chamber (1), the heating device (4) and the liquid driving device (6) form a closed circulation experimental pipeline through the circulation pipeline (2); the heating device (4) is provided with a heating device control panel (5), and the heating device control panel (5) is used to control the heating device (4) and display heating related parameters; the liquid driving device (6) is provided with a liquid driving device control panel (7), and the liquid driving device control panel (7) is used to set the control parameters of the liquid driving device (6) and display the flow rate and pressure data of the circulation pipeline (2); The closed-loop experimental pipeline is filled with an experimental medium; The sample loading cavity (1) is provided with a fixing component, and the fixing component is used to load the polymer medical device to be tested into the sample loading cavity (1); A first branch (21) is provided on any section of the circulation pipeline (2), the first branch (21) being connected to a three-way switch (3), the three-way switch (3) being connected to the first branch (21), an external sampling device and a drug injector; the three-way switch (3) is used for sample / drug injection and sample collection.

2. The implant material dissociation component analysis sample collection device according to claim 1, characterized in that: A second branch (22) is provided on any section of the circulation pipeline (2), the second branch (22) being connected to the circulation pipeline (2) and an external liquid storage bottle (9), and a pressure sensing switch (8) is provided on the second branch (22).

3. The implant material dissociation component analysis sample collection device according to claim 1, characterized in that: The fixing assembly comprises a distance adjusting member and a contact mounting member; the distance adjusting member is mounted on the sample loading chamber (1), the contact mounting member is arranged inside the sample loading chamber (1), and the contact mounting member is connected to the distance adjusting member and can move under the adjustment of the distance adjusting member.

4. The implant material dissociation component analysis sample collection device according to claim 3, characterized in that: The distance adjustment member is a bolt (10), and the contact mounting member is an extrusion plate (11); The bolt (10) is rotatably connected to the sample loading chamber (1); the first end of the bolt (10) is located inside the sample loading chamber (1) and is mounted with the pressing plate (11).

5. The implant material dissociation component analysis sample collection device according to claim 3, characterized in that: The distance adjustment member is a bolt (10), and the contact mounting member is a spring clip (12); The bolt (10) is rotatably connected to the sample loading chamber (1); the first end of the bolt (10) is located inside the sample loading chamber (1) and is installed with the spring clip (12).

6. The implant material dissociation component analysis sample collection device according to claim 1, characterized in that: The fixing components include at least two pairs, and each pair of fixing components is arranged opposite to each other.

7. The implant material dissociation component analysis sample collection device according to claim 4 or 5, characterized in that: The second end of the bolt (10) is provided with a knob.

8. The implant material dissociation component analysis sample collection device according to claim 4 or 5, characterized in that: A sealing member is provided at the location where the bolt (10) and the sample loading chamber (1) meet.

9. The implant material dissociation component analysis sample collection device according to claim 1, characterized in that: The sample loading chamber (1) is a cylindrical sealing structure, an operating port is provided on the cylindrical sealing structure, and a sealing door is provided at the operating port.

10. A method for collecting samples for analysis of dissociated components of implantable materials, implemented based on the device for collecting samples for analysis of dissociated components of implantable materials according to any one of claims 1 to 9, characterized in that: The steps include: The polymer medical device to be tested is loaded into the sample loading cavity (1) through a fixing component; Turn on the liquid driving device (6) and the heating device (4), set the flow rate, flow rate and pressure parameters of the driving device, heat the experimental medium (if necessary), start the circulation, and start the experiment; At a predetermined time point, the valve position of the three-way switch (3) is adjusted to allow the experimental medium to flow out, thereby completing the collection of the experimental medium sample.